positive results from Phase III trial 8/08, 4/09; clinical hold removed 9/09 with initiation of chronic kidney disease patients in near-term; in 2/10 initiated a large-scale Phase 3 trial to demonstrate the lot-to-lot consistency of commercial vaccine and to complete the safety database; shown to be as safe as Energix-B, with no increased risk of auto-immune disorders (3/10)
Brand Heplisav Generic hepatitis B vaccine (recombinant)
Company name Dynavax, Merck Product type Speciality
Therapeutic category Immunologic agents Key uses Hepatitis B
Other Uses N/A Drug Class vaccine
Dosage From IM Expected Approval 2011-Q4
FDA Filing N/A Last Update date March 25,2010
Link to news article
Link to clinicaltrials.gov
Link to press releases